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Outcomes of a new Implantable Collamer Lens in correcting Refractive Errors with Presbyopia

Visual and Refractive outcomes of a new Presbyopia correcting Implantable Collamer Lens in correcting Refractive Errors - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/070484
Enrollment
40
Registered
2024-07-11
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H521- Myopia

Interventions

Intervention1: Ipmplantation of a new Presbyopic ICL: All patients aged between 45 and 55 years with Myopia and Presbyopia will undergo implantation of a new ICL and followed up postoperatively for 12

Sponsors

Nethradhama Super Speciality Eye Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Myopic patients more than -4D and hyperopic patients berween +1 to +10D Best corrected Visual acuityof 20/40 or better No evidence of irregular astigmatism on corneal tomography Anterior chamber depth more than 2.8mm Endothelial cell count more than 2000 cells/mm2

Exclusion criteria

Exclusion criteria: Astigmatism more than 0.5D Progressive or unstable myopia and/or stigmatism. Clinical or topographic evidence of keratoconus Previous ocular surgery. Dysfunctional lens syndrome, any evidence of cataract. Any other active or recurrent ocular diseases. Age related degenerations, any retinal pathology. Corneal scars, opacities, degenarations, Glaucoma, Uncooperative patient

Design outcomes

Primary

MeasureTime frame
Following tests will be performed 1.Uncorrected and Corrected distance visual acuity 2.Uncorrected and Corrected Intermediate visual acuity at 40, 60, 80cm 3.Uncorrected and Corrected near visual acuity 4.Subjective Refraction 5.Intraocular pressure 6.Slit lamp examination for clinical vault and angle 7.Vault angle and height measurements using MS-39 8.Binocular visual acuity for near and distance 9. SRD 10. HDA 11. iTrace 12. Defocus curve 13. FACT 14. Dysphotopsia questionnaireTimepoint: On post-operative day 1, 2 weeks and 12 weeks

Secondary

MeasureTime frame
Following test will be performed 1. slit lamp photographsTimepoint: On post-operative day 2 weeks

Countries

India

Contacts

Public ContactDr Sadhwini M H

Nethradhama Super Speciality Eye Hospital

sadhwiniharish@gmail.com7795568552

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026